Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Staphylococcus Aureus (2058)
|
Event Date 06/20/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
The complaint of infection cannot be confirmed via laboratory testing.(b)(4).
|
|
Event Description
|
It was reported the patient developed a staphylococcal infection at the lead site.The patient had been treated for staphylococcal infection for 8 months prior to the implant procedure.The patient was given antibiotics.
|
|
Manufacturer Narrative
|
Sjm has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Sjm defers to the patient¿s physician regarding medical history.
|
|
Event Description
|
Follow-up revealed the infection had resolved over time.
|
|
Search Alerts/Recalls
|